We are aware of phishing emails targeting speakers of events whose names appear on our events pages. If you are unsure if an email regarding event registration or accommodation has come from us please contact us and do not provide any credit card details or personal information.
This is an essential course for candidates who expect to apply for their QP viva within one year. The course also provides a valuable contribution to Continuing Professional Development for existing QPs and all other managers or supervisors with responsibilities for manufacturing medicinal products.
For those not directly related to manufacturing it provides a valuable overview of the regulatory framework by which medicines are controlled.
The Qualified Person (QP) must have a thorough knowledge and understanding of European and UK Laws related to the manufacture and distribution of medicinal products for human and veterinary use.
This course provides a comprehensive overview of the requirements of the UK Study Guide and, by using interactive questions and scenarios, shows how the Qualified Person or anyone with a responsible position within the pharmaceutical industry can keep up to date and assure compliance.
Learning Outcomes
At the end of the course you will know and understand:
The UK laws and European Directives for the manufacture and distribution of medicinal products for human and veterinary use
Clinical Trial Legislation
Product and Site licensing in the UK and EU
Role and structure of the EMA, MHRA & VMD
Pharmacovigilance requirements
The role of the pharmacopoeias and EDQM
International harmonisation, ICH, PIC/S and Mutual Recognition Agreements
